malignant pleural mesothelioma and pancreatic carcinoma
Conditions
Interventions
A:anti-meso CART cells
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. mesothelin expression positive and histologically confirmed cancer (one of the following): (1) malignant pleural mesothelioma b. pancreatic carcinoma; (2) aged between 18 and 70; 3. persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients with or without liver, lymph node metastasis; 4. tumor is too big to Surgical resection; 5. life expectancy greater than 3 months; 6. satisfactory organ and bone marrow function as defined by the following: (1) creatinine 2; (3) cardiac ejection fraction of >55%; (4) ALT/AST9g/dl, bilirubin 2.0×the institution normal upper limit; (6) absolute neutrophil count >1,000/ul, platelets>75,000/ul; 7. without bleeding disorder or coagulation disorders; 8. dont allergy to Radiocontrast agent; 9. birth control; 10. Adequate venous access for apheresis, and no other contraindications for leukapheresis; 11. Voluntary informed consent is given.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Uncontrolled active infection; 3. Active hepatitis B or hepatitis C infection; 4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary; 5. Previously treatment with any gene therapy products; 6. Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 7. Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokines IL-1beta;cytokine IL-2R;cytokine IL-6;cytokine IL-8;cytokine IL-10;cytokine TNF-alpha;CRP protein;copy numbers of CART in vivo;erythrocyte sedimentation rate; | — |
Countries
China
Contacts
Public ContactAimin Xu
Outcome results
None listed